Efficacy of the Expert System's Ability to Help Detect Critical EventsNCT01240317
eVent in the Human Patient Simulator
An observational study of Efficacy of the Expert System's Ability to Help Detect Critical Events, run by University of British Columbia at 1 site in Canada.
Trial summary
In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Efficacy of the Expert System's Ability to Help Detect Critical Events
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: anesthesiologists, anesthesia residents and fellows
Who may be able to join
- Staff anesthesiologist, fellows and 3rd - 5th year residents will be able to participate in this study.
- Subjects willing to provide informed consent.
Who cannot join
- Inability/failure to provide informed consent.
- Presence of any of the following conditions oPrevious participation in similar experiment oTaken sedative medication within last 24 hours
- Inability/failure to obtain 75% or above in the post-training quiz on the correct use of the eVent.
- Evaluation will be immediately discontinued at request of subject at any point during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)
In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. To do this the investigators plan to use computer based simulations and test it when used by anesthesiologists in a full size human simulator. If these tests are successful the investigators will then be ready to evaluate eVENT on real patients.
Read the detailed description
The development of new sensors or the intelligent synthesis of existing signals (smart sensors) cannot reliably prevent adverse events unless the investigators assimilate the data produced from these devices and provide it to the clinician in a format that is easy to comprehend. The expert system that the investigators are developing will provide intelligent synthesis of data. The clinician focus can then be directed toward the patient rather than continual observation of the monitors.
Clinicians need an expert system to augment vigilance and situation awareness, and to aid in decision making to prevent patient harm.
The development of an expert system to assist the everyday anesthesiologist in the operating room is a significant challenge that is in urgent need of being addressed. Assistance is required in interpreting the overwhelming stream of physiological data, intelligently extracting key features from these data, and bringing them to the attention of the clinician.
- Keywords
- expert system, decision support system, human patient simulator, anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Efficacy of the Expert System's Ability to Help Detect Critical EventsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ansermino, University of British Columbia
- Investigators
- Mark Ansermino, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240317
- Sponsor's protocol ID
- H10-02621
- Status last verified
- Jun 2017
- First submitted
- 10 Nov 2010
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gorges M, Winton P, Koval V, Lim J, Stinson J, Choi PT, Schwarz SK, Dumont GA, Ansermino JM. An evaluation of an expert system for detecting critical events during anesthesia in a human patient simulator: a prospective randomized controlled study. Anesth Analg. 2013 Aug;117(2):380-91. doi: 10.1213/ANE.0b013e3182975b63. Epub 2013 Jun 18.
PubMed 23780423
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- eVENT: An Expert System for Detecting Critical Events During Anesthesia (Human Patient Simulator Study)
- ClinicalTrials.gov ID
- NCT01240317
- Acronym / sponsor ID
- H10-02621
- Keywords
- expert system, decision support system, human patient simulator, anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators are testing the expert system called eVENT. eVENT provides expert advice about the patient's breathing. The investigators have developed and tested a prototype of eVENT and now want to test how it works in practice. To do this the investigators plan to use computer based simulations and test it when used by anesthesiologists in a full size human simulator. If these tests are successful the investigators will then be ready to evaluate eVENT on real patients.
Detailed description
The development of new sensors or the intelligent synthesis of existing signals (smart sensors) cannot reliably prevent adverse events unless the investigators assimilate the data produced from these devices and provide it to the clinician in a format that is easy to comprehend. The expert system that the investigators are developing will provide intelligent synthesis of data. The clinician focus can then be directed toward the patient rather than continual observation of the monitors.
Clinicians need an expert system to augment vigilance and situation awareness, and to aid in decision making to prevent patient harm.
The development of an expert system to assist the everyday anesthesiologist in the operating room is a significant challenge that is in urgent need of being addressed. Assistance is required in interpreting the overwhelming stream of physiological data, intelligently extracting key features from these data, and bringing them to the attention of the clinician.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- anesthesiologists, anesthesia residents and fellows
Key inclusion criteria (2 listed)
- Staff anesthesiologist, fellows and 3rd - 5th year residents will be able to participate in this study.
- Subjects willing to provide informed consent.
Key exclusion criteria (4 listed)
- Inability/failure to provide informed consent.
- Presence of any of the following conditions oPrevious participation in similar experiment oTaken sedative medication within last 24 hours
- Inability/failure to obtain 75% or above in the post-training quiz on the correct use of the eVent.
- Evaluation will be immediately discontinued at request of subject at any point during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Derived from this study: PubMed 23780423Gorges M, Winton P, Koval V, Lim J, Stinson J, Choi PT, Schwarz SK, Dumont GA, Ansermino JM. An evaluation of an expert system for detecting critical events during anesthesia in a human patient simulator: a prospective randomized controlled study. Anesth Analg. 2013 Aug;117(2):380-91. doi: 10.1213/ANE.0b013e3182975b63. Epub 2013 Jun 18.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ansermino principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Efficacy of the Expert System's Ability to Help Detect Critical Events, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01240317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.